Systems and methods for enhancing gas and vapor transfer for tissue treatment devices

ABSTRACT

Embodiments of the invention include methods of tissue/wound treatment and associated devices and systems, including devices for breaching bio-films contained in and around wounds, devices for maximizing moisture vapor transmission rate, and tissue dressings with added barrier features for permeable surfaces.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional ApplicationNo. 60/801,934, filed on May 19, 2006; U.S. Provisional Application No.60/833,112, filed Jul. 24, 2006; U.S. Provisional Application No.60/872,032, filed Nov. 29, 2006 and U.S. Provisional Application No.60/872,700, filed Dec. 4, 2006, each disclosure of which is herebyreference in its entirety.

FIELD OF THE INVENTION

Embodiments of the present invention are directed to devices thatdeliver, transfer and/or maintain gases to a region, and moreparticularly, to tissue treatment devices.

BACKGROUND OF THE INVENTION

Dressings that deliver therapeutic gas to wounds, can be optimized toaddress conditions that warrant the need to enhance the penetration ofthe gases into the tissue, to prevent excess moisture from accumulatingat the wound site, and to preserve the gas in the reservoir.

Some wounds can be problematic with limited vascular access fromunderneath to deliver needed nutrients, repair and infection fightingcomponents to the wounds as well as further localized complications thatcan limit access for topical treatments such as the development ofbio-films, dead tissues and variations in tissue depth, shape and localfluid viscosity.

A subset of wounds consist of collaborative communities or organisms(e.g., anaerobic and aerobic bacteria), where various microbes existwhere they would not otherwise be able to but for other microbes. Forexample, aerobic oxygen consuming microbes can proliferate over asurface allowing oxygen sensitive organisms to thrive underneath wheremore hypoxic conditions can be established (and to a certain extentencased), allowing anaerobes to flourish. In these cases the biofilmsact as a barrier so that such that oxygen or any gas in the environmentexternal to the wound cannot reach the target tissue, fluids or cellspassively by diffusion.

Some wounds have dead and decaying tissue covering, surrounding orthroughout the wounds which also acts as a barrier so that such thatoxygen or any metabolic or therapeutic gas in the environment externalto the wound cannot get to the target tissue and cells.

Sometimes wound topography varies considerably, where some portions canhave a depth that may be minimally impacted by diffusional process fromthe surface, limiting any metabolic or therapeutic gas in theenvironment external to the wound from getting to the target tissue andcells.

Other problems exist in that skin or wounds can over time become asource of excess moisture and moisture vapor. When a film or dressing isplaced over the wound or skin, excess moisture must be moved away fromthe wound to prevent maceration of these tissues. Moisture vaportransmission rate (MVTR) through dressings has been an important featureof wound dressings allowing moisture to essentially evaporate as vaporthrough thin films, foams and microfibers into the surrounding ambientair. The rate of transmission however is dependent upon the externalhumidity. The drier the ambient air, the greater the diffusion gradientacross the film or dressing, and the higher the MVTR. MVTR may begoverned by Fick's Law: MVTR=K×ΔP.¹ Unfortunately in humid environmentsthe effective MVTR is much lower than that reported in the literaturebased upon drier laboratory conditions.¹ http://www.pqri.org/pdfs/whitepaper.pdf

For reservoir based gas delivery devices that provide therapeutic gas toa tissue through permeable, porous or perforated surfaces, there is apotential to lose a fraction of the reservoir contents while removing itfrom the package and securing it onto or into the target tissue. In thiscase, there is a need for protecting these surfaces from releasing gasescontained within or behind prior to delivery to the target tissue.

SUMMARY OF SOME OF THE EMBODIMENTS

Penetration Enhancement of Gases

Some embodiments of the invention present methods and systems for tissuetreatment, especially wound treatment, that include penetrating elementsto penetrate the surface of the wound. Such penetrating elements may beincluded, for example, using a tissue dressing, pre-packaged(preferably) with one or more gases for treating a wound (e.g., oxygen,nitric oxide), examples of which are set forth in Applicant's U.S. Pat.No. 7,014,630 and co-pending U.S. utility patent application Ser. No.11/356,929, filed Feb. 16, 2006 (the '929 application), both disclosuresof which are herein incorporated by reference. Alternatively, suchpenetrating elements may be part of a separate structure that can beused in conjunction with a tissue dressing or other supply of one ormore therapeutic gases.

Accordingly, by adding penetrating elements to some of the embodimentsdisclosed in the '929 application and the '630 patent, one can produce atissue/wound treatment device which can penetrate the surface of thewound (e.g., penetrating the bio-film or other dead cells which cuts offthe interior of the wound from the environment). For example, suchpenetrating elements may be established as a bio-film interrupter,including, for example, protrusions that may be sharp like needles orfinger-like tentacles, and the like (hereinafter “micropenetrators” or“penetration enhancers”) that disrupt the layers of the wound allowingone or more gases from the tissue/wound treatment device access throughthe layers of the wound, and/or perform as conduits/tubes to enable thedelivery of oxygen and/or nitric oxide (for example) to penetrate moreeffectively.

Maximizing Moisture Vapor Transmission Rate

Some embodiments of the invention present wound dressings are optimizedto maximize moisture vapor transmission rate (MVTR) to maintain idealhealing conditions and prevent build up of excess moisture. Accordingly,the present embodiments provide a method to maximize MVTR away from thetissue which is independent of ambient/environmental humidity bymaximizing the diffusion gradient by sequestering moisture vapor into adesiccant its unique reservoir. Such tissue dressing embodiments mayinclude conventional desiccant and/or other hygroscopic media such aspolyacrylates which have been historically used to absorb body fluidssuch urine in diapers directly or to dehumidify closed storagecontainers to preserve moisture sensitive chemicals, or corrosion pronematerials. Such embodiments are applicable to tissue/wound dressings,and other skin coverings including masks for cosmetic and aestheticapplications.

Preserving Gas Inside Porous Reservoirs

In tissue dressing embodiments disclosed in the '630 patent and '929application (as well as FIG. 1 of the present application), someembodiments of the present invention present the use of a second releaseliner which operates as a temporary barrier to a permeable layer/filmprovided with the dressing, while the dressing is removed from itspackage and applied to tissue. Such a release liner enhances theperformance of such tissue dressings by preserving gas inside thereservoirs of such dressings prior to its application. Specifically,after removing such dressings from their containers/packaging, thetherapeutic gases contained such dressings cannot permeate through thepermeable bottom layer of the dressing prior to being placed on a wound.It is only after application of the dressing over the wound, that thepermeable film release liner is removed.

Exemplary Aspects of the Above-Noted Embodiments

Accordingly, in one aspect of the invention, a tissue dressing treatmentdevice is provided and includes a reservoir having contained therein oneor more predetermined gases at concentrations greater than atmosphericand a plurality of micropenetrators capable of penetrating at least aportion of the tissue and enabling gaseous communication of the one ormore gases from the reservoir beyond a surface layer of a target tissuearea.

Another exemplary aspect of the invention is directed to a method oftreating tissue and includes providing a tissue dressing devicecomprising a reservoir having contained therein one or morepredetermined gases at concentrations greater than atmospheric and aplurality of micropenetrators positioned relative to the reservoir so asto enable gaseous communication of the gases contained in the reservoirthrough or adjacent to the micropenetrators, affixing the treatmentdevice around a tissue area, and positioning the micropenetrators intothe tissue area.

Another exemplary aspect of the invention is directed to a tissuedressing apparatus for supplying one or more predetermined gases to atarget area, and includes a top layer, a bottom layer, a reservoir, oneor more predetermined gases at concentrations greater than atmosphericcontained within the reservoir and a plurality of micropenetrators forenabling gaseous communication below the surface of a target area. Thetop layer has gas barrier properties and the bottom layer has gastransfer properties, with the top and bottom layers being sealedtogether to form the reservoir (or being a continuous layer). The tissuedressing apparatus does not generate gas and is packaged prior to usewith the one or more predetermined gases.

Another exemplary aspect of the invention is directed to a tissuedressing apparatus for supplying one or more predetermined gases to atarget area and includes a top layer, a bottom layer, a reservoir, andone or more predetermined gases at concentrations greater thanatmospheric contained within the reservoir. The top layer has gasbarrier properties and the bottom layer has gas transfer properties andextends out beyond the top layer at least along a portion of theperimeter of the tissue dressing. The top and bottom layers are sealedtogether to form the reservoir (or can be a continuous layer), and thetissue dressing apparatus does not generate gas and is packaged prior touse with the one or more predetermined gases.

Another exemplary aspect of the invention is directed to a tissuetreatment device which includes a lattice structure to place over awound, including a first side for facing the target tissue area and asecond side for facing away from the target tissue area. The latticestructure includes a plurality of micropenetrators positioned on thefirst side and traversing from the first side to the second side. Themicropenetrators being capable of penetrating at least a portion of thewound and capable of enabling at least communication of gases through oradjacent to the micropenetrators. Upon providing a source of one or morepredetermined gases at concentrations greater than atmospheric to thesecond side of the material, the one or more gases flow through oradjacent to the micropenetrators and into the wound.

Another exemplary aspect of the invention is directed to a method oftreating a target tissue area, and includes providing a latticestructure to place over a wound, including a first side for facing atarget tissue area and a second side for facing away from the targettissue area, the lattice structure including a plurality ofmicropenetrators positioned on the first side and traversing from thefirst side to the second side. The micropenetrators being capable ofpenetrating at least a portion of wound and capable of enabling at leastcommunication of gases through or adjacent to the micropenetrators. Uponproviding a source of one or more predetermined gases at concentrationsgreater than atmospheric to the second side of the material, the one ormore gases flow through or adjacent to the micropenetrators and into thewound. The method may also include providing a supply of one or moregases, applying the lattice structure over the wound, penetrating thetarget tissue area with the plurality of micropenetrators and enablinggaseous communication between the supply of the one or more gases to themicropenetrators.

Yet another exemplary aspect of the invention is directed to a tissuedressing for maximizing moisture vapor transmission rate (MVTR), andincludes a film for covering a target tissue area having sufficientpermeability to allow moisture vapor to communicate therethrough, a gasreservoir positioned on a side of the film opposite the target tissuearea, and a hygroscopic dessicant material contained within thereservoir. The dessicant material actively absorbs moisture vaporcommunicating through the film thereby maximizing MVTR in and around thetarget tissue area.

Yet another exemplary aspect of the invention is directed to a tissuedressing apparatus for supplying one or more predetermined gases to atarget area and includes a reservoir, a permeable layer provided on atissue facing side of the reservoir and for communicating the one ormore predetermined gases, and one or more predetermined gases atconcentrations greater than atmospheric contained within the reservoir.The tissue dressing apparatus does not generate gas and is packagedprior to use with the one or more predetermined gases and a hygroscopicdessicant material is contained within the reservoir. The dessicantmaterial actively absorbs moisture vapor communicating through thepermeable layer to maximize moisture vapor transmission rate in andaround a target tissue area.

Yet another exemplary aspect of the invention is directed to a tissuedressing apparatus for supplying one or more predetermined gases to atarget area, and includes a top layer, a bottom layer, a reservoir, oneor more predetermined gases at concentrations greater than atmosphericcontained within the reservoir, and a hygroscopic dessicant materialcontained within the reservoir. The dessicant material actively absorbsmoisture vapor communicating through the permeable layer to maximizemoisture vapor transmission rate in and around a target tissue area. Thetop layer has gas barrier properties, the bottom layer has gas transferproperties, and the top and bottom layers are sealed together to formthe reservoir (or be a continuous material), and the tissue dressingapparatus does not generate gas and is packaged prior to use with theone or more predetermined gases.

Yet another exemplary aspect of the invention is directed to a tissuedressing apparatus for supplying one or more predetermined gases to atarget area, and includes a reservoir, a permeable layer provided on atissue facing side of the reservoir and for communicating the one ormore predetermined gases, and one or more predetermined gases atconcentrations greater than atmospheric contained within the reservoir.The tissue dressing apparatus does not generate gas and is packagedprior to use with the one or more predetermined gases. The apparatusalso includes a perimeter adhesive and a perimeter release liner and apermeable layer release liner capable of being released from thepermeable layer after a perimeter of the tissue dressing apparatus isadhered to a target area of tissue.

Yet another exemplary aspect of the invention is directed to a tissuetreatment device and includes a reservoir having contained therein oneor more predetermined gases at concentrations greater than atmospheric,a permeable layer provided on a tissue facing side of the reservoir andfor communicating the one or more predetermined gases and a watersoluble film provided on the permeable layer that restricts gastransfer.

Yet another exemplary aspect of the invention is directed to a tissuedressing apparatus for supplying one or more predetermined gases to atarget area, and includes a reservoir, a permeable layer provided on atissue facing side of the reservoir and for communicating the one ormore predetermined gases, one or more predetermined gases atconcentrations greater than atmospheric contained within the reservoir,wherein the tissue dressing apparatus does not generate gas and ispackaged prior to use with the one or more predetermined gases, anadhesive to attach the reservoir to the tissue; and a release liner thatprotects the permeable layer while it is being removed from the adhesiveand simultaneously allowing the adhesive to adhered to a target area oftissue.

These and other aspects/embodiments, objects and advantages of thepresent invention will be even more apparent with reference to thedetailed description and corresponding figures (briefly describedbelow).

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate one embodiment of the inventionand, together with the description, explain one embodiment of theinvention.

FIG. 1 illustrates one embodiment of a dressing system according to someembodiments of the present invention.

FIG. 2 illustrates a side, cross-sectional view of a tissue/wounddressing device according to some embodiments of the present invention.

FIG. 3 is a perspective, enlarged view of an example of a plurality ofmicropenetraters, comprising a plurality of tubes, according to someembodiments of the invention.

FIG. 4 is a side, enlarged view of another example of a plurality ofneedle-like micropenetrators, according to some embodiments of theinvention.

FIG. 5A illustrates a side, cross-sectional view of a tissue dressinghaving micropenetrators according to some embodiments of the presentinvention.

FIG. 5B illustrates a side, cross-sectional view of a tissue dressinghaving micropenetrators according to some embodiments of the presentinvention being used in conjunction with a wound.

FIG. 6A illustrates a side, cross-sectional view of a tissue dressinghaving micropenetrators and a cavity for enhancing gas delivery, priorto activation, according to some embodiments of the present invention.

FIG. 6B illustrates a side, cross-sectional view of a tissue dressinghaving micropenetrators and a cavity for enhancing gas delivery, afteractivation, according to some embodiments of the present invention.

FIG. 7A illustrates a perspective view of a release liner for use withtissue dressings according to some embodiments of the present invention.

FIG. 7B illustrates a bottom view of a release liner for use with tissuedressings according to some embodiments of the present invention.

FIG. 7C illustrates a side, cross-sectional view of a tissue dressinghaving a release liner according to some embodiments of the invention.

FIG. 7D illustrates a side, cross-sectional view of a tissue dressinghaving a release liner according to some embodiments of the invention.

FIG. 7E illustrates a side, cross-sectional view of a tissue dressinghaving a release liner according to some embodiments of the invention.

FIG. 8A illustrates a side, cross-sectional view of a tissue dressinghaving an extended permeable layer according to some embodiments of theinvention, and including an absorbent foam on a tissue facing side ofthe permeable membrane.

FIG. 8B illustrates a side, cross-sectional view of a tissue dressinghaving an extended permeable layer according to some embodiments of theinvention, and including a porous absorbent material within thereservoir.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates an example of one embodiment of the invention of anapparatus for supplying one or more gases to a target area. Withreference to use of such an embodiment on biological tissue, thisembodiment may be referred to herein as a tissue dressing system 100(also known as a gas-delivery device). The dressing system 100 is shownas an exemplary perspective cut-away view for clearer understanding. Thedressing system 100 may be configured to contain one or morepredetermined gases. While any one or more known gases (or volatiles)may be used, the gases included with the dressing system 100 mayparticularly include oxygen, carbon dioxide, nitrogen and nitric oxide,and combinations thereof. The dressing system can also be used to supplygases to any target areas that would benefit from a locally controlledgas supply such as containers in which it is desired to retard,accelerate, or maintain biochemical reactions, sustain, accelerate,and/or suppress chemical reactions, corrosion, or inhibit the growth orkill organisms.

The dressing system 100 may include a seal 1 10, an external barrier (ortop layer) 120, a reservoir 130, an absorbent ring 140, an adhesivebacking 150, a permeable film (or bottom layer) 180, and may alsoinclude a compliant porous insert 170. As shown, the reservoir may beformed between the upper and lower layers (e.g., being hermeticallysealed around the perimeter), but may also be a separate element to thedressing system, or contained within a continuous layer. To that end, inone embodiment, the seal 110 is configured to bond the external barrier120 and the permeable film 180 together such that the reservoir 130 isformed.

The external barrier 120 is preferably selected to have barrierproperties that allow the therapeutic gases to be contained over theduration of use of the dressing. For example, the external barrier 120may be constructed of metallized polyester, ceramic coated polyester,polyvinylidene chloride laminates such as Saranex®, EVOH laminates suchas Oxyshield®, or polyamide laminates such as Capran®. In oneembodiment, the external barrier 120 may be configured to conduct heator electrical stimulation from an external source to the user. Inanother embodiment for example, polyethylene or another infraredtransmittable material may be utilized as the external barrier 120.

The permeable film 180 is preferably configured to be permeable orporous to gases. For example, the permeable film 180 may be constructedof polyurethane, silicone, polyvinylchloride, polyolefins, ethylenevinyl alcohol (EVA) or EVA/polyethylene.

The reservoir 130 is configured to store a gas while the dressing system100 is worn by a user. In one embodiment, the stored gas within thereservoir 130 is controllably released to the user through the permeablefilm 180. The amount of gas released to the user while wearing thedressing system 100 may vary according to the concentration of the gascontained within the reservoir 130 and the material properties of thepermeable film 180. Other factors such as temperature may also affectthe amount of gas released to the user.

The absorbent ring 140 may be located under to the permeable film 180and may be configured to wick away moisture from the wound or skinsurface. In addition, the adhesive backing 150 is configured to adherethe dressing system 100 to the user. Further, the adhesive backing 150may also be utilized to prevent the gas that is delivered through thepermeable film 180 to the wound from escaping. In one embodiment, theadhesive backing 150 may cover the perimeter of the dressing system 100.In another embodiment, the adhesive backing may cover the entiredressing system 100 and may be integrated with the permeable film 180.

Examples of the types of adhesive that may be used in the presentinvention are described in U.S. Pat. Nos. 6,284,941 and 5,308,887. Inone embodiment, the adhesive backing may be comprised of adhesive usedin commercially available adhesive bandages. In another embodiment, theadhesive backing may be comprised of a gel adhesive. The gel adhesivemay be comprised of a hydrogel. The gel adhesive may also be reusable,such that the dressing system could be removed from the user andreplaced more than once. Examples of gels that may be used are describedin U.S. Pat. Nos. 4,839,345, 5,354,790 and 5,583,114.

The compliant porous insert 170 is configured to prevent gas debt inareas caused by pressing the external barrier 120 directly on to thepermeable film 180. In one embodiment, the compliant porous insert 170placed within the reservoir 130 and between the external barrier 120 andthe permeable film 180.

The proportions of gas-delivery device according to embodiments of thepresent invention (e.g., dressing system 100) may be influenced by thediffusion rates of the relevant gases through the permeable portion(e.g., film 180), the target gas concentration range (e.g., on theuser), and the length of time the gas delivery device is used (e.g., thelength of time the dressing system 100 may be worn). If the gas-deliverydevice includes a seal, then the proportions of the device may be alsoinfluenced by the seal integrity between the dressing system 100 and theuser.

It is worth noting that some embodiments of the present inventioninclude gas infused devices having controlled and/or customized gasdiffusion rates. Specifically, such embodiments may includepre-determined diffusion rates which may be determined by controllingthe type of membrane being used, the size and/or amount of pores and/orerosion areas.

In some embodiments, in addition to providing gas to a target area, thegas-delivery device may be configured to deliver biologically beneficialagents such as drugs, minerals, nutrition, amino acids, pH modifiers,anti-microbials (e.g., antibacterials and antifungals), growth factors,and enzymes to the user. In one embodiment, integrating the deliverysystems of the gas with the beneficial agent additives may lead tosynergistic effects that are not achieved by just the gas or thebeneficial agent additives alone. In one embodiment, these biologicallybeneficial agents may be delivered as microencapsulated agentsincorporated in the adhesive backing 150 that could cover the entire orany portion of the permeable film 180. In another embodiment, themicroencapsulated agents may be available in a gel matrix in thedressing cavity 180, accessible to the wound through pores orperforations, or using conventional transdermal technologies.

In some embodiments, the gas delivery device includes integrally or as aseparate component means to mechanically disrupt the surface of thewound allowing oxygen or other gases to move from the reservoir eitherdirectly or through a series of hollow micro-needles or othermicropenetrators into the depths of the wound fluid or tissues. Bymechanically penetrating passed diffusion barriers caused by biofilms,dead cells or deep irregular wound topography, oxygen (for example) canbe delivered and utilized deeper into the wound bed.

Accordingly, as shown in FIGS. 2-6B, a plurality of micropenetrators maybe included with tissue dressings (e.g., described above with referenceto FIG. 1). Such micropenetrators are advantageous as they can enhancedelivery of a therapeutic gas contained in the reservoir of a tissuedressing to breach any occlusions created by living or dead cells orother bio-films established by the body over the wound. Examples of suchmicropenetrators which could be used with the tissue dressing shown inFIG. 1 can be found with reference to U.S. Pat. Nos. 3,964,482,5,964,729, 6,780,171, 6,503,231, 7,108,681, and 6,780,171, eachdisclosure of which is herein incorporated by reference. Generally,these patents disclose use of such penetrators to bypass the skinbarrier and deliver drugs using a drug delivery patch. The embodimentsaccording to the present invention are not for the purpose of bypassingor penetrating the skin or stratum corneum.

In some embodiments of the present invention, such micropenetrators maybe used as an expanded porous film having elongated pores. Suchelongated pores may include different lengths depending on the type ofwound being treated, or be self adjusting or elongating to accommodatedifferent depths.

In some embodiments, bio-film micropenetrators may in themselves bebeneficial to the wound. Specifically, bioactive materials could be usedas mechanically abrasive to disrupt a bio-film to allow one or moregases to be delivered deeper. For example, bioactive glass/ceramics/solgels disclosed in U.S. Pat. No. 6,428,800 may be manufactured to besharp/penetrating/abrasive for the purpose of disrupting, while alsoproviding the additional bio-beneficial, wound healing and antimicrobialbenefits as described in U.S. Pat. No. 6,756,060, and U.S. patentapplication publication nos. 2004/0151745 and 2004/0166172. For example,particulate bioactive glasses can be used which typically have thefollowing composition by weight percentage: SiO₂ 40-60, CaO 10-30, Na₂O10-35, P₂O₅ 2-8, CaF₂ 0-25, B₂O₃ 0-10, K₂O 0-8, and MgO 0-5. A preferredcomposition of the bioactive glass is: SiO₂ 45, CaO 24.5, Na₂O 24.5, andP₂O₅ 6. A preferred particle size range for the bioactive glass to bepractical as an abrasive is in the range of 10-90 microns.

While the above-described embodiments are particularly useful whencombined with the tissue/wound treatment reservoir-based devicesdisclosed in FIG. 1 (and the '929 application and '630 patent), someembodiments of the present invention may also be useful in oxygengenerating devices (e.g., using hydrogen peroxide and/or otherelectrical, biological, chemical and/or electro-chemical devices).Positive pressure generated from such devices may be used advantageouslyto move gas into the tissue/wound.

Further embodiments with regard to micropenetrators, may include atissue dressing having a positive displacement mechanism (e.g., asqueeze bulb) to provide a positive pressure to transfer a bolus of gasinto wound cavity. An example of such an embodiment can be found inFIGS. 6A and 6B.

Accordingly, FIG. 2 illustrates a side, cross-sectional view of atissue/wound dressing device according to some embodiments of thepresent invention, which includes plurality of micropenetrators 202(e.g., penetration enhancers). As shown, the device may include a gasreservoir 204 (e.g., oxygen, nitric oxide), a porous or otherwisepermeable film 206, a barrier area 208 and adhesive 210.

In general, the micropenetrators may be flexible or rigid, and can bemade of various materials including plastic, metal, bio-activemineral/glass, and the like.

FIG. 3 is a perspective, enlarged view of an example of a plurality ofmicropenetraters, comprising a plurality of tubes 302, which may bepolymer, ceramic and/or metal based. Such tubes may be affixed throughthe permeable film 206 (or an anchoring film used in place of thepermeable film) shown in FIG. 2, or provided on a separate member whichmay be affixed to the permeable film without piercing through the film.Such attachment may allow one end of the micropenetrators to pierce thepermeable/anchoring film upon use of the tissue dressing.

FIG. 4 is a side, enlarged view of another example of a plurality ofmicropenetrators 402. In this example, each micropenetrators maycomprise a needle-like penetrator, which may be solid, or hollow, thelater of which may include one or more openings to allow gaseouscommunication.

FIG. 5A illustrates a side, cross-sectional view of an embodiment of thepresent invention illustrating the use of micropenetrators 502 (enlargedfor illustrative purposes), which may be on the exterior of thereservoir 504, protrude from the porous film 506, or protrude through ananchoring film used in place of the permeable film.

FIG. 5B illustrates the side, cross-sectional view of FIG. 4A, with thedevice placed over a wound 508, and a gas 510 flowing into the wound.

FIGS. 6A and 6B illustrate a positive pressure displacement device, asqueeze bulb 601, which may be a thermo formed cavity (though anexternal device/squeeze bulb may also be used which is in communicationwith the reservoir. Such a squeeze bulb may act as a force-activatedbi-stable dome that upon pressing, can “snap” irreversible down (seeFIG. 6B), expelling a gas volume inside the dome (e.g., twice the volumeof the cavity of the bulb). The gas may be expelled through themicropenetrators 602 and into the wound 608.

In some embodiments of the present invention, an installation tool maybe used to facilitate the processing of disrupting bio-films, tissues orwounds. Such tools are known, being currently used for transdermal,drug-delivery patches. Such tools may be used to effectively createbreaches through tissues/wounds, and then the tissue/wound dressing withmay be applied to the tissue/wound.

Maximizing Moisture Vapor Transmission Rate (MVTR)

State of the art wound dressings and other products such as diaperstoday incorporate absorbent materials to wick away and use high MVTRmaterials to allow moisture vapor to evaporate away from the surface ofwounds and skin. Some embodiments of the present invention presentreservoir based wound dressings which are optimized to maximize moisturevapor transmission rate (MVTR) away from the wound to maintain moisthealing and prevent build up of excess moisture.

MVTR for a film, material or dressing is characterized under constantconditions, and is typically governed by thickness and materialproperties (K). Moisture vapor transmission or diffusion rates are alsoproportional to the diffusion gradient (ΔP), which is dependent on thelevel of moisture vapor on both sides. The drier the ambient air, thegreater the diffusion gradient across the film or dressing, and thehigher the MVTR. MVTR may be governed by Fick's Law: MVTR=K×ΔP.²² http://www.pqri.org/pdfs/whitepaper.pdf

When a film or dressing is placed over the wound or skin, ambient air onthe outside varies in humidity. Thus when the wound is exuding highlevels of moisture and the environmental humidity in non-laboratoryconditions is high, the effective MVTR across the dressing in use on apatient can be zero because there is no diffusion gradient when theambient air outside the dressing is saturated in high humidity.

Accordingly, in some embodiments of the invention such as in FIGS. 1 or2, which is illustrated as a tissue/wound dressing but can be used in aform applicable to other skin coverings (e.g., masks), hygroscopic ordessicant materials that absorb moisture and moisture vapor can beincluded in the reservoir which contains the one or more therapeuticgases. Ideally these materials would be the same or similar to materialsused currently to dehumidify closed containers such as silica gel,polyacrylates or bentonite clay. However, in this invention, thedessicants are not being used prevent the corrosion or chemicalbreakdown of materials and drugs, but rather is being uniquely used tomaximize the moisture vapor diffusion gradient away from the wound,across the permeable film side of the reservoir, so as to make the MVTRindependent from ambient environmental humidity. One embodiment wouldbind the dessicant material in the reservoir to all surfaces in thereservoir excluding the permeable surface, so as to maximize thepermeable film surface area, and therefore further maximizing themoisture vapor transfer rate by maximizing the area of transfer.

Thus, according to some embodiments for this invention, moisture vaportransmission rates may be maximized by sequestering away vapor as itmoves away from the wound by creating a controlled dehumidifying spaceover the moisture source, the skin and the wound. To that end, someembodiments of the present invention include methods and systems whichsequester moisture vapor to maximize MVTR, specifically by maximizingthe diffusion gradient for moisture vapor. Since some materials canabsorb up to 1000 times their weight in moisture, a relatively smallamount of hygroscopic material can absorb a large amount of moisture.

For example, in one embodiment, a reservoir based dressing (e.g., seeFIG. 1) maximizes MVTR by using a desiccant in a reservoir, whichconsists of (for example): a film 180 covering a wound having sufficientpermeability to allow moisture vapor to pass through such aspolyurethane; a second, barrier type film 120 sealed along an edge ofthe first film creating a gas reservoir in between; and a hygroscopicdessicant material such as powders or films made of polyacrylates placedin the reservoir to actively absorb moisture vapor that moves into thecavity.

By making component the permeable film highly permeable to moisturevapor, e.g., 1000-4000 gm/m²/day, and making a barrier film with lowerMVTR, a system may be created which operates independently from theatmospheric conditions that limit the effective in-use MVTR of currentdressings. The dessicant material may be a material such as such aspolyacrylate powder, fibers and beads, silca gel, Bentonite clay,sodium, potassium, or calcium crystalline hydrated aluminosilicates,synthetic dessicants.

The above described MVTR embodiments may be used with the tissuedressing apparatuses disclosed herein or in Applicant's U.S. Pat. No.7,014,630 and co-pending U.S. utility patent application Ser. No.11/356,929, filed Feb. 16, 2006 (the '929 application).

Preserving Gas Inside Porous Reservoirs

In order to insure that the gases contained in the reservoir of varioustissue dressing embodiments according to the present invention (e.g.,see FIG. 1), the porous/permeable surface may be covered with a releaseliner that is removed as a pull tab after the dressing is placed on atarget area intended to receive the gas delivery. Specifically,according to the present embodiment, a tissue dressing as described withreference to FIG. 1 (or the '630 patent and/or '929 application)preferably includes two (2) release liners: a perimeter release liner702 covering and protecting the adhesive around the perimeter of thetissue dressing, and a permeable layer-pull tab release liner 704covering the perforations that communicate with the reservoir to coverand protect the adhesive as well as block gas transmission from thereservoir to the atmosphere during handling. In another embodiment, thepull tab release liner is provided adjacent an absorbent media which isprovided between the release liner and the perforations of the tissuedressing that communicate with the reservoir (preferably, the media isattached thereto). Such absorbent media may include polyurethane foam,gauze, hydrocellular foam, alginates, hydrogel, and hydrocolloids (forexample).

In some embodiments of the invention, the perimeter and permeable layerrelease liners may be incorporated into a single release liner, which ispulled off via one or more pull tabs.

The use of the permeable barrier release liner operates as a temporarybarrier while the dressing is removed from its package and applied totissue enhances the gas delivery performance of tissue dressings. Thus,when using such a tissue dressing, the tissue dressing may be removedfrom its packaging, and the permeable film release liner is removed andthe dressing is secured over the wound except for the portion coveredwith the pull tab. Accordingly, the permeable film release liner 704 isthen removed by pulling a tab 704 a which sticks out from under thewound dressing, sliding it out from between the dressing 700 and theskin, and then securing the remaining portion of the adhesive backedbottom layer 702 over and around the wound. For some embodiments, eitherthe permeable film release liner 704 or the top barrier layer 706 shouldbe sufficiently permeable so as to allow the gases in the reservoir (aswell as the storage container) to come to equilibrium over an extendedperiod of time during storage in a positively pressurized (preferably)package.

Accordingly, as shown in FIGS. 7A-7E, a tissue dressing 700 according tothe present embodiment includes 706 barrier layer holds gas in the gasreservoir 708, which preferably includes a compliant porous insert (notshown) that is an absorbent sponge-like material; perforated orpermeable bottom (for example) film/layer 710 which allows minimalrestricted gas transfer properties with an adhesive backing, releaseliner 702 which protects the perimeter adhesive; and permeable filmrelease liner 704 having a pull tab 704 a. As shown, preferably, thepull tab for the permeable film release liner is connected to the end ofthe release liner located opposite the end of the dressing where thepull tab is positioned. This may be accomplished using extra releaseliner material (as shown in the figures), or by some other means (e.g.,natural or synthetic thread and the like).

Other embodiments of the permeable film release liner aspect of thepresent invention may include a small hole in the permeable film releaseliner 704 that allows for direct two-way gas transfer between the gas inthe reservoir and the gas in the container that the dressing is storedin. The hole size can be optimized based upon the perforated holepattern in the permeable film such that at least a portion of one holeis always overlapping with any hole in the permeable film. Suchembodiments may allow the gases in the reservoir and the storagecontainer (e.g., packaging) to come to equilibrium in pressure or gasconcentrations over time, if either the barrier layer 706 or thepermeable film release liner 704 are not sufficiently permeable or havepermeabilities that are significantly different for the different gasesmoving into and out of the reservoir.

Still other embodiments of this aspect of the present invention requireno adhesive on the portion of the permeable film 710 under the reservoir708 portion of the dressing. In such embodiments, the design may bemodified to make the perimeter release liner 702 narrower inside thanthe perimeter adhesive such that the permeable film release liner 704 iswide enough to overlap to cover the perimeter adhesive exposed by theperimeter release liner 702.

In other embodiments, the permeable film is protected by covering thepores with a water soluble film (for example) that will disintegrateupon wetting (e.g., upon contact with wound fluid, the filmdisintegrates). Such an embodiment, thus, need not require a permeablefilm release liner. Examples of water soluble films that may be usedinclude: starch/cellulose/rice paper type media, polyvinyl alcohol orplga(poly(lactide-co-glycolide) films. Such materials also allow forloading of beneficial agents described in the '630 patent.

In still other embodiments, the permeable film release liner includesfolds such that the release liner preferably rolls both off of thedressing and across the wound rather than dragging across the woundsurface. It is worth noting that with respect to the illustratedembodiments, gaps and other features are exaggerated to betterillustrate the geometry (e.g., the permeable film release liner wouldlay flat without gas between the layers). Accordingly, in someembodiments, the permeable film release liner may be one layer thickwith no folds (FIG. 7C), two layers with a fold opposite the pulldirection (with the pull tab protruding from the top or bottom; FIG.7D), or multiple folds (FIG. 7E). Each design includes particularbenefits and may also include certain compromises, depending (forexample) on pore size, surface characteristics of the porous surface,adhesive location and type, acceptable gas dilution specs, and woundsurface type (for example).

In yet other embodiments of the present invention, a tissue dressingdevice is presented as set out in FIGS. 8A and 8B. As shown, bothfigures illustrate a tissue dressing 800. In FIG. 8A, the tissuedressing includes a barrier layer 802, a reservoir 804, a permeablemembrane (which is sealed with the barrier layer) 806 which extends outbeyond the barrier layer either along one portion of the tissuedressing, or preferably extending out along the entire perimeter orsubstantially the entire perimeter of the dressing. By extending thepermeable layer out beyond the edge of the tissue dressing (i.e.,barrier material), the perimeter adhesive and corresponding skin isbetter able to “breath”, gaseous communication, with the environmentexternal to the wound. This enables the adhesive, and thus the tissuedressing, a longer use life. The embodiment shown in FIG. 8A includes anabsorbent foam material 808 on the tissue facing side of the permeablelayer, while in FIG. 8B, the absorbent foam is provided within thereservoir (not shown).

The foregoing descriptions of specific embodiments of the invention havebeen presented for purposes of illustration and description. They arenot intended to be exhaustive or to limit the invention to the preciseembodiments disclosed, and naturally many modifications and variationsare possible in light of the above teaching. The embodiments were chosenand described in order to explain the principles of the invention andits practical application, to thereby enable others skilled in the artto best utilize the invention and various embodiments with variousmodifications as are suited to the particular use contemplated.

1. A tissue dressing treatment device comprising a reservoir havingcontained therein one or more predetermined gases at concentrationsgreater than atmospheric; and a plurality of micropenetrators capable ofpenetrating at least a portion of the tissue and enabling gaseouscommunication of the one or more gases from the reservoir beyond asurface layer of a target tissue area.
 2. The device according to claim1, wherein the micropenetrators comprise a plurality of microtubes. 3.The device according to claim 1, wherein the micropenetrators comprise aplurality of needle structures.
 4. The device according to claim 1,wherein the tissue dressing device comes pre-packaged with the one ormore predetermined gases contained in the reservoir.
 5. The deviceaccording to claim 1, wherein the tissue dressing does not generate theone or more predetermined gases.
 6. The device according to claim 1,wherein the tissue dressing further comprise gas generating means forgenerating the one more predetermined gases.
 7. The device according toclaim 1, further comprising a positive pressure device for creating apositive pressure within the reservoir to actively displace the one ormore predetermined gases through or adjacent to the micropenetrators. 8.The device according to claim 7, wherein the positive pressure devicecomprises a squeeze bulb.
 9. The device according to claim 7, whereinthe positive pressure device comprises an external source of the one ormore predetermined gases.
 10. A method of treating tissue comprising:providing a tissue dressing device comprising a reservoir havingcontained therein one or more predetermined gases at concentrationsgreater than atmospheric and a plurality of micropenetrators positionedrelative to the reservoir so as to enable gaseous communication of thegases contained in the reservoir through or adjacent to themicropenetrators; affixing the treatment device around a tissue area;and positioning the micropenetrators into the tissue area.
 11. Themethod according to claim 10, further comprising creating an increasedpressure within the reservoir to actively drive the one or more gasesthrough or adjacent to the micropenetrators.
 12. A tissue dressingapparatus for supplying one or more predetermined gases to a targetarea, comprising: a top layer; a bottom layer; a reservoir; one or morepredetermined gases at concentrations greater than atmospheric containedwithin the reservoir, and a plurality of micropenetrators for enablinggaseous communication below the surface of a target area, wherein: thetop layer has gas barrier properties, the bottom layer has gas transferproperties, the top and bottom layers are sealed together to form thereservoir, and the tissue dressing apparatus does not generate gas andis packaged prior to use with the one or more predetermined gases. 13.The tissue dressing according to claim 12, wherein the top and bottomlayers are continuous.
 14. A tissue dressing apparatus for supplying oneor more predetermined gases to a target area, comprising: a top layer; abottom layer; a reservoir; one or more predetermined gases atconcentrations greater than atmospheric contained within the reservoir,and wherein: the top layer has gas barrier properties, the bottom layerhas gas transfer properties and extends out beyond the top layer atleast along a portion of the perimeter of the tissue dressing, the topand bottom layers are sealed together to form the reservoir, and thetissue dressing apparatus does not generate gas and is packaged prior touse with the one or more predetermined gases.
 15. The tissue dressingaccording to claim 14, wherein bottom layer has an adhesive backing. 16.A tissue treatment device comprising: a lattice structure to place overa wound, including a first side for facing the target tissue area and asecond side for facing away from the target tissue area, the latticestructure including a plurality of micropenetrators positioned on thefirst side and traversing from the first side to the second side,wherein the micropenetrators being capable of penetrating at least aportion of the wound and capable of enabling at least communication ofgases through or adjacent to the micropenetrators, wherein uponproviding a source of one or more predetermined gases at concentrationsgreater than atmospheric to the second side of the material, the one ormore gases flow through or adjacent to the micropenetrators and into thewound.
 17. A method of treating a target tissue area comprising:providing a lattice structure to place over a wound, including a firstside for facing a target tissue area and a second side for facing awayfrom the target tissue area, the lattice structure including a pluralityof micropenetrators positioned on the first side and traversing from thefirst side to the second side, wherein the micropenetrators beingcapable of penetrating at least a portion of wound and capable ofenabling at least communication of gases through or adjacent to themicropenetrators, wherein upon providing a source of one or morepredetermined gases at concentrations greater than atmospheric to thesecond side of the material, the one or more gases flow through oradjacent to the micropenetrators and into the wound; providing a supplyof one or more gases; applying the lattice structure over the wound;penetrating the target tissue area with the plurality ofmicropenetrators; and enabling gaseous communication between the supplyof the one or more gases to the micropenetrators.
 18. A tissue dressingfor maximizing moisture vapor transmission rate (MVTR) comprising: afilm for covering a target tissue area having sufficient permeability toallow moisture vapor to communicate therethrough; a gas reservoirpositioned on a side of the film opposite the target tissue area; ahygroscopic dessicant material contained within the reservoir, whereinthe dessicant material actively absorbs moisture vapor communicatingthrough the film thereby maximizing MVTR in and around the target tissuearea.
 19. The tissue dressing according to claim 18, wherein thedessicant material is selected from the group consisting of:polyacrylate powder, fibers and beads, silca gel, Bentonite clay,sodium, potassium, and calcium crystalline hydrated aluminosilicates,synthetic dessicants.
 20. A tissue dressing apparatus for supplying oneor more predetermined gases to a target area, comprising: a reservoir; apermeable layer provided on a tissue facing side of the reservoir andfor communicating the one or more predetermined gases; one or morepredetermined gases at concentrations greater than atmospheric containedwithin the reservoir, wherein the tissue dressing apparatus does notgenerate gas and is packaged prior to use with the one or morepredetermined gases; and a hygroscopic dessicant material containedwithin the reservoir, wherein the dessicant material actively absorbsmoisture vapor communicating through the permeable layer to maximizemoisture vapor transmission rate in and around a target tissue area. 21.The tissue dressing according to claim 20, wherein the dessicantmaterial is selected from the group consisting of: polyacrylate powder,fibers and beads, silca gel, Bentonite clay, sodium, potassium, andcalcium crystalline hydrated aluminosilicates, synthetic dessicants. 22.A tissue dressing apparatus for supplying one or more predeterminedgases to a target area, comprising: a top layer; a bottom layer; areservoir; one or more predetermined gases at concentrations greaterthan atmospheric contained within the reservoir, and a hygroscopicdessicant material contained within the reservoir, wherein the dessicantmaterial actively absorbs moisture vapor communicating through thepermeable layer to maximize moisture vapor transmission rate in andaround a target tissue area, wherein: the top layer has gas barrierproperties, the bottom layer has gas transfer properties, the top andbottom layers are sealed together to form the reservoir, and the tissuedressing apparatus does not generate gas and is packaged prior to usewith the one or more predetermined gases.
 23. The tissue dressingaccording to claim 22, wherein the top and bottom layers are continuous.24. A tissue dressing apparatus for supplying one or more predeterminedgases to a target area, comprising: a reservoir; a permeable layerprovided on a tissue facing side of the reservoir and for communicatingthe one or more predetermined gases; one or more predetermined gases atconcentrations greater than atmospheric contained within the reservoir,wherein the tissue dressing apparatus does not generate gas and ispackaged prior to use with the one or more predetermined gases; aperimeter adhesive and a perimeter release liner; and a permeable layerrelease liner capable of being released from the permeable layer after aperimeter of the tissue dressing apparatus is adhered to a target areaof tissue.
 25. A tissue treatment device comprising a reservoir havingcontained therein one or more predetermined gases at concentrationsgreater than atmospheric; a permeable layer provided on a tissue facingside of the reservoir and for communicating the one or morepredetermined gases; and a water soluble film provided on the permeablelayer that restricts gas transfer.
 26. The device according to claim 25,wherein the water soluble film is selected from the group consisting of:paper type media of starch, cellulose, or rice, polyvinyl alcohol, andplga(poly(lactide-co-glycolide).
 27. A tissue dressing apparatus forsupplying one or more predetermined gases to a target area, comprising:a reservoir; a permeable layer provided on a tissue facing side of thereservoir and for communicating the one or more predetermined gases; oneor more predetermined gases at concentrations greater than atmosphericcontained within the reservoir, wherein the tissue dressing apparatusdoes not generate gas and is packaged prior to use with the one or morepredetermined gases; an adhesive to attach the reservoir to the tissue;and a release liner that protects the permeable layer while it is beingremoved from the adhesive and simultaneously allowing the adhesive toadhered to a target area of tissue.